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Recall Observatory FDA recall evidence

Device product

Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080055

Z-1881-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
2520 units
Official record key
device-enforcement:Z-1881-2023

Official wording

Reason: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Code information: UDI/DI 14026704341266, Batch Numbers: 18FG02, 18IG29, 18KG28, 19AG39, 19BG02, 19CT64, 19GT31, 19IT33, 20DT18, KME20G0435, KME20K2579, KME21K0764, KME21K1278, KME22B0079, KME22B0080, KME22E2802, KME22H2250

Distribution pattern: US Nationwide distribution including Puerto Rico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.